wrist blood pressure monitor, blood pressure pills recalled

We can hardly believe this. The FDA announced there are additional blood pressure pills recalled. Yup, you guessed it! The FDA is expanding the valsartan recall…again! We have lost count of how many times the Food and Drug Administration has had to revise its list of companies that are in trouble because of contaminated valsartan. In addition, there’s a recall for the most prescribed blood pressure pill in the world: hydrochlorothiazide (HCTZ). It is a diuretic. According to our calculations, over 20 million Americans swallow it daily.

HCTZ Blood Pressure Pills Recalled?

Let’s start with the new recall. It’s a crisis! A pharmacy discovered that its 100-count bottles of hydrochlorothizide (abbreviated HCT or HCTZ) contained a different diuretic by mistake. The manufacturer was Accord Healthcare. Instead of 12.5 mg of HCTZ, the bottles contained 25 mg of spironolactone. Trust us when we tell you that this is a potentially life-threatening mistake (more details below).

Here is the FDA’s August 27, 2018, release:

“Accord Healthcare Inc. is voluntarily recalling One lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, to the consumer level.

“A 100 count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market. Based on findings of both preliminary and interim investigations carried out at the manufacturing site, Accord believes that no other lots of Hydrochlorothiazide Tablets are involved in this mix-up. Accord became aware of this finding through a product complaint reported from a pharmacy.

“Spironolactone tablets are indicated in the management of primary hyperaldosteronism, edematous conditions for patients with congestive heart failure, cirrhosis of the liver accompanied by edema and/or ascites, nephrotic syndrome, essential hypertension, hypokalemia, severe heart failure. Use of spironolactone tablets instead of hydrochlorothiazide tablets, poses the risk of contracting hyperkalemia (increase potassium levels) in certain individuals resulting in adverse events that range from limited health consequences to life-threatening situations in certain individuals. To date, Accord has not received any reports of adverse events related to this recall.”

“Hydrochlorothiazide tablets are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effectiveness of other antihypertensive drugs in the more severe forms of hypertension.

“Accord’s Hydrochlorothiazide Tablets USP 12.5 mg are light orange to peach colored, round, biconvex tablets debossed with H on one side and 1 on another side.”

Why Is this Such A Big Deal?

Hydrochlorothiazide depletes the body of potassium. It’s usually not that big a deal, but it needs to be monitored. Physicians may prescribe it with a blood pressure drug that preserves potassium. That way there is a delicate balance between the two so that potassium levels stay in the sweet spot. An example might be an ACE inhibitor like lisinopril. It helps the body retain potassium. There are even combination pills that contain both lisinopril and HCTZ.

The trouble is that spironolactone, also a diuretic, preserves potassium. If you were to combine lisinopril (which also preserves potassium) together with spironolactone you could end up with excessive potassium buildup (hyperkalemia). Too much potassium can lead to irregular heart rhythms or sudden cardiac death. People with kidney problems are especially vulnerable to hyperkalemia, but even healthy people can succumb.

How Would You Know Whether Your HCTZ Is Recalled?

First, look to see if you are taking 12.5 mg tablets. That should be on the label. Get out your magnifying glass and see if you can find the name of the manufacturer, Accord Healthcare, Inc. While you are at it, check to see if the pharmacy put a lot number on your bottle of pills. To our dismay we have discovered that many pharmacies do not do this. The lot number of the Accord Healthcare recall is PW05264. If you are unsure, CALL your pharmacy and ask who the manufacturer of your hydrochlorothiazide is and what lot number the pharmacy used to fill your prescription.

Where Did the Mixup Occur?

We went searching for Accord Healthcare. What we found was a glowing mission statement:

“Our mission is to join the hospitals, pharmacists, wholesalers, and other front-line healthcare providers in the vital delivery of life-sustaining drugs to their patients.

“By placing orders with the highest levels of precision, taking personal and mutual responsibility for support needs, and considering the patient’s well-being as our primary goal, we continue to foster Accord Healthcare’s enduring reputation for quality and integrity.

“As we support front-line healthcare providers through accurate delivery of high-quality pharmaceuticals, our focus is on the patients who require our medications for relief from illness and the restoration of health. Our success is measured by the trust we cultivate in the medical community who increasingly look to us as a dependable resource.”

This sounds impressive, but we would have to conclude that Accord Healthcare had quality control problems based on their mislabeling of spironolactone. We also discovered that Accord Healthcare is

“an emerging large-scale provider of generic pharmaceuticals in the United States. Our U.S. headquarters is in Durham, North Carolina, near the Research Triangle Park (RTP).”

The Head Office Address:

Corporate House
Nr. Sola Bridge, S.F. Highway,
Thaltej
Ahmedabad – 380 054, India

We have no idea where the mislabeling occurred.

The Valsartan Scandal Continues!

HCTZ are not the only blood pressure pills recalled this week. We can hardly believe it, but the FDA has once again expanded the list of companies that have sold contaminated valsartan. To read about the history of this debacle, go to this link.

The Valsartan Recall Disaster Keeps Getting Worse, Not Better

On August 24, 2018 the FDA noted that

“Torrent Pharmaceuticals Limited is expanding its voluntary recall. FDA has updated the list of valsartan products under recall.”

“Torrent Pharmaceuticals Limited is expanding its voluntary recall to all lots of unexpired valsartan-containing drug products due to the detection of NDMA in the active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.

“RemedyRepack, a repackager of Torrent’s valsartan/amlodipine/hydrochlorothiazide (HCTZ) tablets, has also recalled.”

You can find a list of the valsartan products under FDA recall at this link:

The People’s Pharmacy Perspective:

Enough! We are sick and tired of these mistakes. We hope you noted that it was not the FDA that discovered the disastrous mistake with hydrochlorothiazide. It was a pharmacist! A vigilant guardian of our health caught a potentially lethal error. Next time you fill your prescription, please take a moment to thank the pharmacist for taking time to check for quality and for drug interactions.

And please let your legislators know that you would like country of origin information placed on every medicine that is dispensed in the U.S. If you know where your shoes and shirts come from, why not your pills?

Share your own thoughts below in the comment section.

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  1. Mitch
    Boca Raton
    Reply

    I’m a victim of the Valsartan disaster. I took it for three years. My doctor prescribed losartan, and I felt it wasn’t working as well so they changed it to Irbesartan. I went to Walgreens to have it filled and this time I asked where it was made. TO MY SHOCK – the rep said, “New Jersey” – but I asked, wait – is it SOLCO Healthcare? They said, “Yes.” I said look more carefully at the label, where is it manufactured. He then said, “Oh, you’re right” it was Zhejiang Huahai Pharma in China – the same company that made the bad Valsartan. Why is Walgreens still using this generic manufacturer??? I won’t buy any generics made in China. People must ask these questions!!!

  2. Kristin E
    Georgia
    Reply

    Any idea when or if Valsartan will be cleaned up and begin manufacturing again? I am finding Lorsartan is harsher on me.

  3. Nancy
    FL
    Reply

    I have been on (the recalled) valsartan for several years. I had to call my pharmacy to check. I knew before they did. They had to check. They exchanged them for one made in the US. And, now I have pre-cancerous cells in my breast and will be having a lumpectomy. Coincidence?

  4. Julie
    TX
    Reply

    I recently had my prescription for HCTZ renewed after a lapse of several months. When I picked this up yesterday from CVS, I asked the pharmacist if the pills were not part of the recall. She laughed nervously, and said that a lot of people had picked up these pills, and so it must be okay. Really? !!!! She didn’t know ANYTHING about the recall, nor did she take me seriously. I am really questioning whether I go back to CVS.

  5. Shari
    NC
    Reply

    I took my husband’s prescription for Hydrochlorothiazide 112.5 mg tablets in to the Walgreen’s where I purchased it. The pharmacist said his was in the recalled batch according to this information put out by the FDA. She gave me the number to call for Accord. When I called, the person I talked with said ours was not the pill that was recalled-so the FDA information was incorrect. She said the recalled pill is yellow and has an AB on it. This is very confusing and does not make us trust the information that is coming from the FDA-nor from the pharmacist!

  6. Sara
    Leland, NC
    Reply

    My HCTZ 12.5 mg pills match the description exactly, but there’s no lot number on the bottle. When I went to Walgreens to check it out, I was given a print out with a number to call about the recall. When I did so, the person answering said it was only the 25 mg yellow pills that were recalled. I found this hard to believe since both your column and the Walgreens print out identified the 12.5 mg pills as problematic, but the fellow on the phone was adamant that was not the recalled item. I’m not sure what steps to take next. Can you help?

  7. Berge
    Banner Elk, NC
    Reply

    I recently had an experience at the WalMart Pharmacy in Boone.
    I take Dofetilde 250 mcg # 60 per month using 1 caps twice a day for which I pay $159,54
    But when I checked the bottle before I paid I saw it was 125 mcg # 60 for $159.54 which meant not only half the dose but for the same price, so If I took 4 capsules a day I would run out of medicine in 15 days , paying twice as much for my monthly need.
    In addition the doctors name was not my doctor .
    So how a pharmacy make such a mistake , especially when we pay $159 for a month supply for a generic medication on the market more than 18 years. So Obviously a pharmacy will not notify us about a recall , when they can not fill a coorect dose of a medicine

    • Mary
      Greensboro
      Reply

      I too called that number, and the lady was adamant that my lot was safe and that the recall was the yellow one, which does not fit the description of the recall. This sounds dangerous enough to stop taking until can confer with a physician for an alternative or nothing.

  8. Chris
    Reply

    HCTZ was prescribed to lower my idiopathic high potassium level. I am beyond grateful for your column addressing the recall of Accord’s generic formula. My prescription matches the recall without verification of lot number. Should I feel safe if lot numbers don’t match? I’m concerned that this medicine could be having the opposite effect of its intended one.

  9. Ellen
    Maryland
    Reply

    I have been checking the recall lists every time it was expanded and my Valsartan finally made the last recall. And the only way I knew is because I get a 90 day supply so instead of my pharmacy filling the prescription in their bottle they give me three 60 count bottles in which the medication comes to them directly from the U.S. distributor. These bottles have the code that was listed in the recall list. I do not believe this code is listed on a regular pharmacy prescription bottle. Now I have a new blood pressure medication which also comes from China. I’m not happy that just about all our meds and over the counter supplements come from China and/or India. We are at their mercy.

  10. Florence
    New Jersey
    Reply

    When I called my pharmacy on 8/31 I asked about the HCTZ recall which had occurred officially about 24 hours before. The pharmacist knew nothing about it. I then asked, ‘In the event of a recall do you notify your customers i they purchased about the recall?’ The pharmacist told me “No” it was up to my insurance company to notify me. I was shocked since that could take my large insurance company a week or more to notify its customers!!

    Is there any way to fix this serious delay/breakdown in communication to advise the public more quickly. Fortunately, I subscribe to The People’s Pharmacy but what about the poor folks who do not?

    • Joe Graedon
      Reply

      We are shocked and saddened to learn that your pharmacy would not notify you of a recall. When we purchased canned beans from our grocery store several years ago we were notified promptly that there had been a recall. If grocery stores can do that with food items we would think pharmacies could do the same thing when it comes to recalled medicines. We think this is a serious shortcoming in our drug-supply system. The FDA should be spearheading an effort to improve this situation!

  11. Janice
    Texas
    Reply

    I agree with compulsory disclosure of country of origin on all medicine bottles. ( prescription or over the counter)

    I was on Valsartan for years but discontinued due to recent disclosures. I am now on Losartan/HCT 100-12.5MG and I am extremely disappointed as it does not work for me.

    Could you name some reliable blood pressure meds I can ask my doctor about? I feel like I’m groping around in the dark. Thank you. Janice Good

    • Joe Graedon
      Reply

      Our Guide to Blood Pressure Treatment lists a number of options. It is available in our store.

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